Apparatus and method for inserting an adjustable implantable genitourinary device

ABSTRACT

An implantable medical device and method for adjustably restricting a selected body lumen such as a urethra or ureter of a patient to treat urinary incontinence or ureteral reflux. The device includes an adjustable element and a tubular elongate body, where the adjustable element includes a chamber and the tubular elongate body includes at least a first interior passageway which extends longitudinally in the tubular elongate body from a first opening at the proximal end to a second opening in fluid communication with the chamber. Fluid volume passed through the first passageway is used for adjustably expanding or contracting the adjustable element. The implantable medical device further includes a sheath, where the sheath includes a wall having an inner surface which defines a channel through which at least a portion of the implantable device can pass. Alternatively, the implantable medical device includes a tip suitable to penetrate tissue so that the implantable medical device can be implanted within the tissue of a patient.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This patent application is a continuation of U.S. application Ser. No.09/416,193, filed on Oct. 11, 1999 now U.S. Pat. No. 6,579,224, thespecification of which is herein incorporated by reference in itsentirety.

FIELD OF THE INVENTION

The invention relates generally to implantable medical devices and inparticular to implantable medical devices for coaptation of a bodylumen.

BACKGROUND OF THE INVENTION

Various implantable devices, such as inflatable/distensible medicaldevices, are known in which the distensible medical devices areimplanted into the tissue of a human to treat urinary incontinence.These devices have typically relied upon restricting or constricting theurethra of the patient to maintain continence.

U.S. Pat. No. 4,733,393 to Haber et al. is an attempt at such a proposeddevice. U.S. Pat. No. 4,733,393 relates to a hypodermically implantablegenitourinary prosthesis which provides an extensible, inflatable tissueexpanding membrane to be located in proximal urethral tissue to add bulkto these tissues for overcoming urinary incontinence by localizedincrease in tissue volume.

U.S. Pat. No. 4,802,479 to Haber et al. is an attempt at an instrumentfor dispensing and delivering material to an inflatable membrane of agenitourinary prosthesis within the tissues of a patient for overcomingurinary incontinence. U.S. Pat. No. 4,832,680 to Haber et al. relates toan apparatus for hypodermically implanting a genitourinary prosthesiscomprising an extensible containment membrane for retaining a fluid orparticulate matter which is injected from an external source.

U.S. Pat. No. 5,304,123 to Atala et al. relates to a detachable membranecatheter incorporated into an endoscopic instrument for implantationinto the suburethral region of a patient. Also, U.S. Pat. No. 5,411,475to Atala et al. discusses a directly visualized method for deploying adetachable membrane at a target site in vivo. U.S. Pat. No. 5,830,228 toKnapp et al. relates to a method and system for deployment of adetachable balloon at a target site in vivo.

Once inflated, these devices maintain pressure on the urethra of thepatient in an attempt to assist with continence. However, these devicesare prone to being under or over inflated at time of implant, leading toundesirable postoperative results. For example, if the devices areoverinflated it may cause the urethra to be restricted too tightly, andthe patient is at risk for retention, a condition where the patientcannot pass urine. Such a condition could lead to kidney damage,necessitating major corrective surgery or at minimum use ofself-catheterization to empty the bladder on a regular basis thusincreasing the risk of urinary tract infection.

Furthermore, once these devices have been implanted within the patient,the only means of removing them in the event of a postoperative problemor device malfunction is through major surgery. Also, the devices arenot secured within the tissues of the patient, so there is thepossibility of the devices migrating back along the pathway created ininserting them, a problem which has been noted with prior art devices.Thus, an important medical need exists for an improved implantabledevice for treating urinary incontinence.

SUMMARY OF THE INVENTION

The present invention provides an implantable device and a method forits use in restricting a body lumen. In one embodiment, the bodylumen-is a urethra, where the implantable device is used to coapt theurethra to assist the patient in urinary continence. The implantablemedical device has the advantage of being adjustable both at the time ofimplantation and postoperatively. This postoperative adjustability ofthe implantable medical device allows a physician to regulate the amountof pressure applied to the urethra to ensure continence of the patientand to minimize iatrogenic effects.

In one embodiment, the present subject mater includes an implantabledevice assembly for controllable coaption of a body lumen. Theimplantable device assembly includes an implantable device whichincludes an adjustable element and a tubular elongate body. Theadjustable element includes a continuous wall, including an innersurface defining a chamber. The tubular elongate body includes aperipheral surface, a proximal end and a distal end, where theperipheral surface is connected to and sealed to the adjustable element.The tubular elongate body further includes at least a first interiorpassageway which extends longitudinally in the tubular elongate bodyfrom a first opening at the proximal end to a second opening in fluidcommunication with the chamber of the implantable device. This allowsfor adjustably expanding or contracting the adjustable element byapplied flowable material introduced through the first opening. Theimplantable device assembly also includes a sheath, where the sheathincludes a wall having an inner surface which defines a channel throughwhich at least a portion of the implantable device can pass.

In one embodiment, the implanted device is inserted into body tissue bypassing the device through the sheath. The sheath is first inserted intothe tissue of the patient and then the implanted device is moved throughthe channel of the sheath. In one embodiment, the implanted device ismoved through the sheath through the use of a push rod, where the pushrod is inserted into the first interior passageway. As the push rod isinserted into the first interior passage way it comes into contact witha closed end distal to both the first opening and second opening of thefirst interior passage way. Force can then be applied to the push rod tomove the implanted device at least partially through the channel of thesheath.

In an alternative embodiment, the tubular elongate body includes asecond interior passageway which extends longitudinally along at least aportion of the tubular elongate body from an inlet to a closed end. Thesecond interior passageway is of sufficient diameter to receive the pushrod which contacts the closed end to allow force applied to the push rodto move the implanted device at least partially through the channel ofthe sheath.

In an additional embodiment, the implantable device assembly can furtherinclude a sleeve having a longitudinal slot, where at least a portion ofthe implanted device is housed in the volume defined by the sleeve. Inone embodiment, the sleeve and implanted device are passed through thesheath so as to extend the adjustable element past the distal end of thesheath. The adjustable element is then expanded so that contact is madewith the tissue. In one embodiment, the sheath is withdrawn from thebody, after which the sleeve is then either passed around a portion ofthe implanted device or a portion of the implanted device deforms toallow the implanted device to pass through the sleeve. In an alternativeembodiment, the sleeve is withdrawn from the body, after which thesheath is passed around a portion of the implanted device.

In an additional embodiment, the implantable device includes a rear portelement coupled to the proximal end of the tubular elongate body. In oneembodiment, the rear port element is releasably attached to the tubularelongate body. The rear port element including a cavity in fluidcommunication with the first opening of the first interior passageway.This allows for fluid volume passed through the rear port element toeither expand or contract the size of the adjustable element. In oneembodiment, the rear port element has an elastic septum to receive aneedle through which flowable material can pass to expand or contractthe adjustable element.

The sheath of the present subject matter also includes a first portionand at least one of a second portion, where the second portion is of alesser strength compared to the first portion. In one embodiment, thesecond portion extends longitudinally along the wall to allow for thewall of the sheath to be separated. In one embodiment, the secondportion of the wall includes scorings extending longitudinally along thewall which create a weak area over which the sheath can be torn. In anadditional embodiment, the wall of the sheath can include two scoringsextending longitudinally along the wall to allow for the sheath to beseparated into two pieces. Alternatively, the sheath can include a slitthrough the wall, where the slit extends longitudinally along the wall.

In an additional embodiment, the implanted device further includes a tipsuitable to penetrate tissue. In one embodiment, the tip is positioned,or is formed, at the distal end of the tubular elongate body.Alternatively, the distal end of the push rod forms the tip, where thetip is exposed at the distal end of the tubular elongate body when thedistal end of the push rod passes through an outlet end in the secondinterior passage way.

Finally, an important feature of the implantable device of the presentinvention relates to the adjustable element or membrane which isaccessible for subsequent adjustment in volume through the rear portelement located under a patient's skin, remotely from the adjustableelement. Another important feature of the present invention over theprior art devices is the convenient in vivo postoperative adjustabilityof both pressure and size of the adjustable element.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of an implantable device assembly accordingto one embodiment of the present subject matter, where a sheath is shownin cross-sectional view to reveal an implantable device;

FIG. 2 is a schematic cross-sectional view of the implantable deviceassembly according to one embodiment of the present subject matter;

FIG. 3 is a schematic cross-sectional view of the implantable deviceassembly according to one embodiment of the present subject matter;

FIG. 4A is a schematic of the implantable device assembly according toone embodiment of the present subject matter;

FIG. 4B is a schematic of the implantable device assembly according toone embodiment of the present subject matter;

FIG. 5 is a schematic of an implantable device according to oneembodiment of the present subject matter;

FIG. 6A is a schematic cross-sectional view of the implantable deviceassembly according to one embodiment of the present subject matter;

FIG. 6B is a schematic end view of the implantable device assemblyaccording to one embodiment of the present subject matter

FIG. 7A is a schematic view of a sheath according to one embodiment ofthe present subject matter;

FIG. 7B is a schematic view of a sheath according to one embodiment ofthe present subject matter;

FIG. 7C is a schematic view of a sheath according to one embodiment ofthe present subject matter;

FIG. 8A is a schematic view of a sheath according to one embodiment ofthe present subject matter;

FIG. 8B is a schematic view of a sheath according to one embodiment ofthe present subject matter;

FIG. 9 is a schematic view of a sheath according to one embodiment ofthe present subject matter;

FIG. 10 is a schematic view of a sheath according to one embodiment ofthe present subject matter;

FIG. 11 is a schematic view of a sheath according to one embodiment ofthe present subject matter;

FIG. 12A is a schematic cross-sectional view of the implantable deviceassembly according to one embodiment of the present subject matter;

FIG. 12B is a schematic cross-sectional view of the implantable deviceassembly according to one embodiment of the present subject matter;

FIG. 13 is a schematic of an implantable device according to oneembodiment of the present subject matter;

FIG. 14 is a schematic of an implantable device according to oneembodiment of the present subject matter;

FIG. 15 is a schematic of an implantable device assembly according toone embodiment of the present subject matter; and

FIG. 16 is a method according to one embodiment of the present subjectmatter.

DETAILED DESCRIPTION OF THE INVENTION

In the following detailed description, reference is made to theaccompanying drawings which form a part hereof and in which is shown byway of illustration specific embodiments in which the invention may bepracticed. These embodiments are described in sufficient detail toenable those skilled in the art to practice and use the invention, andit is to be understood that other embodiments may be utilized and thatlogical, and structural changes may be made without departing from thespirit and scope of the present invention. The following detaileddescription is, therefore, not to be taken in a limiting sense and thescope of the present invention is defined by the appended claims andtheir equivalents.

The present subject matter describes embodiments of an implantabledevice assembly and/or an implantable device for restricting a bodylumen. In one embodiment, the present subject matter is for treatingurinary incontinence by implanting at least one of the implantabledevices adjacent the urethra. In an alternative embodiment, the presentsubject matter is for treating ureteral reflux of a patient byimplanting at least one of the implantable devices adjacent one or bothureter proper. Additionally, the present subject matter is useful intreating urinary stress incontinence resulting from male post radicalprostatectomy, esophageal reflux, fecal incontinence or vascularrestriction.

Implantable devices designed for treating urinary incontinence aretypically referred to as a genitourinary prosthesis. Many designs forgenitourinary prosthesis have been proposed. In one such proposedembodiment, the genitourinary prosthesis comprises an implantable devicewhich includes a rear port element coupled to a tubular elongate bodyand an adjustable element, where the adjustable element has a chamberdesigned to receive a measured supply of flowable material introducedthrough the rear port element to inflate the prosthesis. One suchdescription of a genitourinary prosthesis is also provided in a U.S.patent application Ser. No. 08/928946, entitled “ADJUSTABLE IMPLANTABLEGENITOURINARY DEVICE” filed Sep. 12, 1997, by Burton et al., which ishereby incorporated by reference in its entirety.

In treating urinary incontinence, the prosthesis is delivered within thebody to a location that is typically within the periurethral tissue andadjacent to the urethra to enable a patient to overcome urinaryincontinence by means of increasing both localized tissue volume andpassive occlusive pressure upon the urethral mucosa. The implantabledevice of the present subject matter is useful for accomplishing thisobjective, while the implantable device assembly of the present subjectmatter is useful in delivering the implantable device to a desiredlocation within the body of the patient.

Referring now to FIG. 1, there is shown one embodiment of an implantabledevice assembly 100 according to the present subject matter. In oneembodiment, the implantable device assembly is for delivering into abody an implantable device 110 for the controllable coaption, orrestriction, of a body lumen. In one embodiment, the implantable device110 is for treating ureteral reflux of a patient by implanting at leastone of the implantable device 110 adjacent one or both ureter proper. Inan alternative embodiment, the implantable device 110 is for treatingurinary incontinence by implanting at least one of the implantabledevice 110 adjacent the urethra.

In FIG. 1, the implantable device 110 is shown to include an adjustableelement 120 and a tubular elongate body 130. In one embodiment, theadjustable element 120 includes a continuous wall, including an innersurface defining a chamber. The tubular elongate body 130 includes aperipheral surface 140, a proximal end 150 and a distal end 160, wherethe peripheral surface 140 is connected to and sealed to the adjustableelement 120. The implantable device 110 is shown positioned within asheath 170, where the sheath 170 includes a wall 180 having an innersurface 184 which defines a channel 188 through which at least a portionof the implantable device 110 can pass. In the embodiment shown in FIG.1, a cross sectional view of the sheath 170 is shown so as to reveal theimplantable device 110 positioned at least partially within the channel188.

Referring now to FIG. 2, there is shown a schematic cross-sectional viewof the implantable device assembly 200 according to one embodiment ofthe present subject matter. An implantable device 202 is shown toinclude an adjustable element 204 and a tubular elongate body 206. Inone embodiment, the adjustable element 204 includes a continuous wall208, including an inner surface 210 defining a chamber 212. The tubularelongate body 206 includes a peripheral surface 214, a proximal end 216and a distal end 218. The adjustable element 204 has at least oneopening through the continuous wall 208 to which the peripheral surface214 is connected to and sealed to the adjustable element 204.

In one embodiment, a first portion 220 and a second portion 222 of theinner surface 210 of the adjustable element 204 and the peripheralsurface 214 are sealed using a chemical or polymer adhesive, such assilicone. In an alternative embodiment, the peripheral surface 214 issealed to the first portion 220 and the second portion 222 using sonicwelding techniques as are known in the art. The final result of bondingthe first portion 220 and the second portion 222 of the inner surface210 of the adjustable element 204 to the peripheral surface 214 of thetubular elongate body 206 is that a fluid tight bond or seal is createdbetween the inner surface 210 of the adjustable element 204 and theperipheral surface 214 of the tubular elongate body 206.

In one embodiment, the tubular elongate body 206 includes at least afirst interior passageway 230 which extends longitudinally in thetubular elongate body 206 from a first opening 232 at the proximal end216 to a second opening 234. In one embodiment, the second opening 234is in fluid communication with the chamber 212 of the implantable devicefor adjustably expanding or contracting the adjustable element 204 byflowable material introduced through the first opening 232. In oneembodiment, the fluid tight bonding at the first portion 220 and thesecond portion 222 allows for the chamber 212 to maintain pressureprovided by the flowable material so that the size of the adjustableelement 204 can be changed.

In one embodiment, the adjustable element 204 is constructed of abiocompatible resiliently elastomeric polymer or polymer blend ofpolyurethane, silicone, or the like. In this embodiment, the wall 208stretches as the adjustable element 204 expands or contracts to adesired size. In an alternative embodiment, the continuous wall 208 isconstructed of a biocompatible non-resilient polymer or polymer blend ofpolyethylene, polyethyleneterephthalate (PET), polyurethane, highmodulus polystyrene, polyesteretherketone (PEEK), or other nonresilientpolymers as known. In this embodiment, the continuous wall 208 of theadjustable element 204 expand to a predetermined shape. The adjustableelement 204 is formed into a variety of shapes. In one embodiment, theouter surface of the continuous wall 208 generally defines a sphericalshape. In an alternative embodiment, the outer surface of the continuouswall 208 generally defines an elongate body having semi-spherical endportions.

In one embodiment, the continuous wall 208 of the adjustable element 204has a length and a diameter when inflated to operating volume, where thedimension of the length and diameter are selected in a range fromone-half (0.5) centimeter to five (5) centimeters, where each of thelength and diameter are selected independently. Alternatively, theadjustable element 204 can have a length and a diameter that are equal(length=diameter) so as to give a generally spherical shape to theadjustable element. In one embodiment, the adjustable element 204 has aspherical shape with a length and diameter of up to three (3)centimeters. In an alternative embodiment, the adjustable element 204has a spherical shape with a length and diameter of up to one andone-half (1.5) centimeters.

Other configurations of length and diameter are possible so as to giveadjustable elements 204 of different shapes. For example, the adjustableelement can have an elliptical or kidney cross-sectional shape tofacilitate at least partially surrounding the body lumen with theadjustable element, where the adjustable element is concave relative tothe urethral lumen. The dimensions discussed for the adjustable elementapply to all embodiments of the present subject matter.

In one embodiment, the first interior passageway 230 includes a closedend 240, where the closed end 240 is positioned distal to both the firstopening 232 and second opening 234. The closed end 240 is of sufficientstrength and hardness to receive a distal end 242 of a push rod 244,where the closed end 240 transfers force applied at a proximal end 246of the push rod 244 to the implantable device 202.

In one embodiment, the first interior passageway 230 is of sufficientdiameter to receive the push rod 244 which contacts the closed end 240to allow force applied to the push rod 244 to move the implanted device202 at least partially through a channel 250 of a sheath 254. In oneembodiment, the implantable device 202 is shown positioned within thesheath 254, where the sheath 254 includes a wall 256 having an innersurface 260 which defines the channel 250 through which at least aportion of the implantable device 202 can pass.

In one embodiment, the push rod 244 has a length between a first end ana second end of the push rod in a range of ten (10) to forty (40)centimeters, a diameter of between 0.05 to 0.16 centimeters, where thediameter of the push rod will depend upon the construction material forthe rod. In one embodiment, the push rod is made of stainless steel.Alternatively, the push rod is made of a plastic. In an additionalembodiment, the push rod is made of a material having a yield strengthgreater than 12,000 psi.

In an additional embodiment, a detectable marker is imbedded in theimplantable device 202. For example, the detectable marker 270 islocated at the distal end 218, (e.g., the tip) of the tubular elongatebody 206. Alternatively, the detectable marker could be located in thecontinuous wall 208 of the adjustable element 204. The detectable marker270 allows the adjustable element 204 to be located and its shape to bevisualized within the tissues of a patient using any number ofvisualization techniques which employ electromagnetic energy as a meansof locating objects within the body. In one embodiment, the detectablemarker 270 is constructed of tantalum and the visualization techniquesused to visualize the adjustable element 204 are x-ray or fluoroscopy asare known in the art. In an additional embodiment, the sheath could alsohave a detectable marker, where the marker could be incorporated into,or on, the wall of the sheath. Alternatively, the entire sheath could beconstructed so as to be radio opaque.

Referring now to FIG. 3, there is shown a schematic cross-sectional viewof an implantable device assembly 300 according to one embodiment of thepresent subject matter. The implantable device assembly 300 is shown toinclude an implantable device 302. The implantable device 302 includesan adjustable element 304 and a tubular elongate body 306. In oneembodiment, the adjustable element 304 includes a continuous wall 308,including an inner surface 310 defining a chamber 312. The tubularelongate body 306 includes a peripheral surface 314, a proximal end 316and a distal end 318. In one embodiment, the peripheral surface 314 isconnected to and sealed to the adjustable element 304.

In one embodiment, a first portion 320 and a second portion 322 of theinner surface 310 of the adjustable element 304 is chemically bonded tothe peripheral surface 314 of the tubular elongate body 306.Alternatively, the first portion 320 and/or the second portion 322 ofthe inner surface 310 of the adjustable element 304 is mechanicallyand/or thermally welded to the peripheral surface 314 of the tubularelongate body 306. The final result of bonding the first portion 320 andthe second portion 322 of the inner surface 310 of the adjustableelement 304 to the peripheral surface 314 of the tubular elongate body306 is that a fluid tight bond or seal is created between the innersurface 310 of the adjustable element 304 and the peripheral surface 314of the tubular elongate body 306.

In one embodiment, the tubular elongate body 306 includes a firstinterior passageway 330 and a second interior passageway 332. In oneembodiment, the first interior passageway 330 extends longitudinally inthe tubular elongate body 306 from a first opening 334 at the proximalend 316 to a second opening 336. In one embodiment, the second opening336 is in fluid communication with the chamber 312 of the implantabledevice for adjustably expanding or contracting the adjustable element304 by flowable material introduced through the first opening 334. Inone embodiment, the fluid tight bonding at the first portion 320 and thesecond portion 322 allows for the chamber 312 to maintain volumeprovided by the flowable material so that the size of the adjustableelement 304 can be changed. In one embodiment, the first interiorpassageway 330 includes a closed end 342, where the closed end 342 ispositioned distal to both the first opening 334 and second opening 336.

In one embodiment, the second interior passageway 332 extendslongitudinally along at least a portion of the tubular elongate body 306from an inlet 344 to a closed end 346. In one embodiment, the secondinterior passageway 332 is of sufficient diameter to receive a push rod350 which contacts the closed end 346 to allow force applied to the pushrod 350 to move the implanted device 302 at least partially through achannel 354 of a sheath 358. In one embodiment, the closed end 346 is ofsufficient strength and hardness to receive a distal end 352 of the pushrod 350, where the closed end 346 transfers force applied at a proximalend 354 of the push rod 350 to the implantable device 302. In oneembodiment, the force applied to the push rod 350 moves the implanteddevice 302 at least partially through the channel 354 of the sheath 358.In one embodiment, the implantable device 302 is shown positioned withinthe sheath 358, where the sheath 358 includes a wall 360 having an innersurface 362 which defines the channel 354 through which at least aportion of the implantable device 302 can pass.

In one embodiment, the second interior passageway 332 forms a portion ofthe tubular elongate body and extends from the inlet located at theproximal end 316 of the tubular elongate body 306 to the closed end 346located at or proximal to the distal end 318 of the tubular elongatebody 306. Alternatively, the second interior passageway 332 extendslongitudinally within the tubular elongate body 306 for only a portionof the overall length of the tubular elongate body 306, as is shown inFIG. 3.

In an additional embodiment, a detectable marker is imbedded in theimplantable device 302. For example, the detectable marker 370 islocated at the distal end 318, (e.g., the tip) of the tubular elongatebody 306. Alternatively, the detectable marker could be located in thecontinuous wall 308 of the adjustable element 304. The detectable marker370 allows the adjustable element 304 to be located and its shape to bevisualized within the tissues of a patient using any number ofvisualization techniques which employ electromagnetic energy as a meansof locating objects within the body. In one embodiment, the detectablemarker 370 is constructed of tantalum and the visualization techniquesused to visualize the adjustable element 304 are x-ray or fluoroscopy asare known in the art. In an additional embodiment, the sheath could alsohave a detectable marker, where the marker could be incorporated into,or on, the wall of the sheath. Alternatively, the entire sheath could beconstructed so as to be radiopaque.

Referring now to FIG. 4A, there is shown a schematic of an implantabledevice assembly 400 according to one embodiment of the present subjectmatter. The present implantable device assembly 400 includes a sheath404, where the sheath 404 includes an elongate body 408 having a wall412. The wall 412 includes an inner surface 416 which defines a channel420. Included within the channel 420 is a sleeve 424. The sleeve 424includes a wall 430 having an outer surface 434 and an inner surface438. In one embodiment, the outer surface 434 and the inner surface 438define an arc, or a partial cylinder or curved portion, of the wall 430.In one embodiment, the arc of the wall 430 has a first dimension, suchas a radius of curvature, with respect to the outer surface 434 of thewall 430 which permits the sleeve 424 to be positioned within thechannel 420 of the sheath 404. In addition, the first dimension of thesleeve is of a size which permits the sleeve 424 to move longitudinallywithin the channel 420 of the sheath 404 as is shown by arrow 440.

In one embodiment, the sleeve 424 includes a channel 444 between a firstedge 446 and a second edge 448 on the wall 430 of the sleeve 424. In oneembodiment, the first edge 446 and the second edge 448 of the channel444 are parallel and extend longitudinally along the length of thesleeve 424. Alternatively, the first edge 446 and the second edge 448 ofthe channel 444 converge or diverge, or both, longitudinally along thelength of the sleeve 424. The inner surface 438 of the sleeve 424includes a second dimension, that is smaller than the first dimension ofthe outer surface, where the second dimension allows for a volume 460 tobe defined. In one embodiment, the second dimension is of a radius forthe inner surface of the arc defined by the wall 430. The volume 460 isof sufficient size to permit the tubular elongate body and theadjustable element of the implantable device 462 to fit in the volume460 defined by inner surface 438 of the sleeve 424. In one embodiment,the implantable device 462 is of the type previously described.

The implantable device 462 is placed in the volume 460 defined by thesleeve 424 and the sleeve 424 and the implantable device 462 are theninserted into the channel 420 of the sheath 404. Once inside the sheath404, the implantable device 462 and the sleeve 424 are advanced throughthe sheath 404 by applying force to either the sleeve 424 or to theimplantable device 462. In one embodiment, force applied to the sleeve424 is provided by pushing or pulling at one or more points along thewall 430 of the sleeve 424. When positioned in the sleeve 424 and thesheath 404, the implantable device 462 has sufficient contact with thewall 430 of the sleeve 424 to prevent the adjustable member 472 of theimplantable device 462 from slipping along the wall 430. In other words,the dimensions of the outer surface of the adjustable member 472 and theinner surface 438 of the sleeve 424 provide for frictional forcessufficient to prevent the implantable device 462 to move relative to thesleeve 424 as the sleeve and implantable device are moved through thesheath.

Referring now to FIG. 4B there is shown an alternative embodiment of animplantable device assembly 473 according to one embodiment of thepresent subject matter. The present implantable device assembly 473includes a sheath 474, where the sheath 474 includes an elongate body475 having a wall 476. The wall 476 includes an inner surface 477 whichdefines a channel 478. The implantable device assembly 473 furtherincludes a sleeve 479. The sleeve 479 includes a wall 480 having anouter surface 481 and an inner surface 482. In one embodiment, the outersurface 481 and the inner surface 482 define an arc, or a partialcylinder or curved portion, of the wall 480. In one embodiment, the arcof the wall 480 has a an inner diameter with respect to the innersurface 482 of the wall 480 which permits the sleeve 479 to bepositioned around the peripheral surface 483-of the tubular elongatebody 484 of the implantable device 462. The sleeve 479 also includes aproximal end 484 and a distal end 485, where the distal end abuts aridge, or ledge, formed at the point where the peripheral surface 483 ofthe tubular elongate body is connected to and sealed to the adjustableelement 472.

The sleeve 479 allows for the implantable device 462 to be advancedthrough the sheath 474 by force applied at the distal end 485 of thesleeve 479. Once the adjustable element 472 has been advanced past thedistal end of the sheath 474, the adjustable element 472 can be expanded(as shown) to fix the position of the implantable device 462 in thetissue of a patient. The adjustable element 472 is expanded by fluidvolume introduced into the first interior passageway 487. In oneembodiment, once expanded, the sheath 474 is withdrawn from the body.The sleeve 479 is then either pulled, or slid, off the tubular elongatebody 484, or the tubular elongate body 484 is passed through the slot488 of the sleeve 479. Alternatively, once expanded, the sleeve iseither pulled, or slid, off the tubular elongate body 484 or the tubularelongate body 484 is passed through the slot 488 of the sleeve 479. Thesheath 474 is then withdrawn from the body.

In one embodiment, the sleeve 479 has an inner diameter that is betweenzero (0) to five (5) percent larger than the diameter of the tubularelongate body 484. Additionally, the sheath, as described in any of thepresent embodiments, has an inner diameter that is in a range of between1.27 to 3.81 millimeters (or 0.050 inches to 0.150 inches). In oneembodiment, the outer diameter of the sheath, as described in any of thepresent embodiments, has an outer diameter that is in a range of between0.171 millimeters to 0.514 millimeters (0.0675 inches to 0.2025 inches),where the outer diameter is determined based on the type of materialused to construct the sheath. In an alternative embodiment, the outerdiameter of the sheath can be larger than 0.514 millimeters, where thefinal outer diameter of the sheath depends on the material used and thedesired stiffness of the sheath. In one embodiment, the sheath is madeof stainless steel. Alternatively, the sheath is made of a polymer,polymer blend and/or co-polymer, or a combination there of. For example,the sheath can be made of polyurethane or PEEK.

Referring now to FIG. 5 there is shown a schematic cross-sectional viewof an implantable device assembly 500 according to one embodiment of thepresent subject matter. As previously described, the implantable deviceassembly 500 includes an implantable device 502 having an adjustableelement 504 and a tubular elongate body 506, where the tubular elongatebody 506 includes at least a first interior passageway 510 which extendslongitudinally in the tubular elongate body 506 from a first opening 512at the proximal end 516 to a second opening 520, and where theimplantable device 502 is shown positioned within a channel 524 of asheath 526. In one embodiment, the implantable device assembly 500 issimilar to the implantable device assembly described from FIG. 2.

The implantable device assembly 500 further includes a rear port element530, where the rear port element 530 is coupled to the proximal end 516of the tubular elongate body 506. In one embodiment, the rear portelement 530 is coupled to the proximal end 516 of the elongate body 506using chemical adhesives, or alternatively, using sonic weldingtechniques as are known in the art. In an additional embodiment, therear port element 530 and proximal end 516 are formed together in apolymer molding process, such as liquid injection molding, as are knownin the art.

The rear port element 530 includes a cavity 536, where the cavity 536 isin fluid communication with the first opening 512 of the elongate body506. In one embodiment, the rear port element 530 also includes anelastic septum 540 through which the cavity 536 is accessed, where theelastic septum 540 is a sealable after repeated pierces, for example,with a needle. In one embodiment, the elastic septum 540 is retained inthe rear port element 530 by a clamp ring 550 located around the rearport element 530. In one embodiment, the clamp ring 550 is made of abiocompatible material, such as, for example, titanium. In oneembodiment, the elastic septum 540 is made of a biocompatible material,such as, for example, silicone or polyurethane. The rear port element530 has an outer diameter defined by outer surface 554 of the rear portelement 530, where in one embodiment the rear port has an outer diameterof one (1) millimeter to ten (10) millimeters, (1) millimeter to six (6)millimeters, where four and one-half (4.5) millimeters is an possiblediameter. The dimensions discussed for the rear port element apply toall embodiments of the present subject matter.

In one embodiment, the outer surface of the rear port element 530 andthe adjustable element 504 are of a size (e.g., a diameter) that issmaller than an inner size (e.g., a diameter) of the channel 524 toallow the implantable device 502 to be moved longitudinally through thechannel 524 of the sheath 526. In an alternative embodiment, the rearport element 530 is constructed of at least one material flexible enoughto allow the size of the rear port element 530 in its relaxed state tobe compressed to a size sufficiently small so that the implantabledevice 502 can be moved longitudinally through the channel 524 of thesheath 526. For the present embodiments, the tubular elongate body 506has a stiffness sufficient to allow force applied at the proximal end ofthe tubular elongate body to move the implantable device at leastpartially through the channel of the sheath. In one embodiment, thestiffness of the tubular elongate body is determined based on the typeof material used in constructing the tubular elongate body.Alternatively, support elements can be added to the tubular elongatebody. For example, a metal coil can be placed longitudinally within thetubular elongate body to increase the stiffness of the tubular elongatebody.

Once the implantable device 502 is positioned within a body, theadjustable element 504 is inflated by releasably connecting a flowablematerial source to the rear port element 530. In one embodiment, theflowable material source includes a syringe with a non-coring needle,where the needle is inserted through the elastic septum 540. A measuredsupply of fluid volume can be introduced into the implantable device,where the adjustable element 504 expands or contracts due to a volume offlowable material introduced into the cavity 536 of the rear portelement 530 from the flowable material source. The adjustable element504 is then used to at least partially and adjustably restrict the bodylumen. Fluids suitable for infusing into the prothesis include, but arenot limited to, sterile saline solutions, polymer gels such as siliconegels or hydrogels of polyvinylpyrrolidone, polyethylene glycol, orcarboxy methyl cellulose for example, high viscosity liquids such ashyaluronic acid, dextran, polyacrylic acid, polyvinyl alcohol, or aradio-opaque fluid for example. Once the adjustable element 504 has beeninflated, the needle is withdrawn from the septum of the rear port 530.

In an additional embodiment, a detectable marker 570 is imbedded in thecontinuous wall of the adjustable element 504. The detectable marker 570allows the adjustable element 504 to be located and its shape to bevisualized within the tissues of a patient using any number ofvisualization techniques which employ electromagnetic energy as a meansof locating objects within the body. In one embodiment, the detectablemarker 570 is constructed of tantalum and the visualization techniquesused to visualize the adjustable element 504 are x-ray or fluoroscopy asare known in the art.

In an additional embodiment, a detectable marker is imbedded in theimplantable device 502. For example, the detectable marker 570 islocated at the distal end 560, (e.g., the tip) of the tubular elongatebody 506. Alternatively, the detectable marker could be located in thecontinuous wall of the adjustable element 504. The detectable marker 570allows the distal end 560, or the adjustable element 504, to be locatedand its shape to be visualized within the tissues of a patient using anynumber of visualization techniques which employ electromagnetic energyas a means of locating objects within the body. In one embodiment, thedetectable marker 570 is constructed of tantalum and the visualizationtechniques used to visualize the distal end 560, or the adjustableelement 504, are x-ray or fluoroscopy as are known in the art. In anadditional embodiment, the sheath could also have a detectable marker,where the marker could be incorporated into, or on, the wall of thesheath. Alternatively, the entire sheath could be constructed so as tobe radioopaque.

Referring now to FIG. 6A, there is shown a schematic cross-sectionalview of an implantable device assembly 600 according to one embodimentof the present subject matter. As previously described, the implantabledevice assembly 600 includes an implantable device 602 having anadjustable element 604, a tubular elongate body 606, and a detectablemarker 605 imbedded at the distal end of the tubular elongate body 606where the tubular elongate body 606 includes at least a first interiorpassageway 610 which extends longitudinally in the tubular elongate body606 from a first opening 612 at the proximal end 616 to a second opening620, and where the implantable device 602 is shown positioned within achannel 624 of a sheath 626. In the present embodiment, the adjustableelement 604 is shown with a lower profile as compared to the otherembodiments of the adjustable elements. In one embodiment, this lowerprofile is due to the adjustable element 604 being preshaped. In oneembodiment, when the adjustable element 604 has no fluid volume insideits chamber, the walls of the adjustable element 604 can be foldedaround the tubular elongate body to provide for the lower profile. Oneexample of folding the adjustable element 604 is shown in FIG. 6B.Folding the adjustable element 604 around, or onto, the tubular elongatebody can also be done with any of the embodiments shown in the Figures.

The implantable device assembly 600 further includes a rear port element630, which is releasably coupled to the proximal end 616 of the tubularelongate body 606. In one embodiment, the rear port element 630 includesa rear port wall 632 having an inner surface 634 and an outer surface638. In an additional embodiment, the rear port element 630 includes anelastic septum 636. The inner surface 634 of the rear port wall 632defines a cavity 634 and a rear port lumen 640, where the rear portlumen 640 has a lumen outlet 644. The lumen outlet 644 can then becoupled to the first interior passageway 610 to provide fluidcommunication between the cavity 634 and the chamber 650 of theadjustable element 604.

In one embodiment, the outer surface 638 of the rear port wall 632 isadapted to be coupled to the inner surface 646 of the tubular elongatebody 606. For example, the outer surface 638 of the rear port element630 can include one or more barbs 660 which are adapted to engage orseat in the wall 662 of the tubular elongate body 606 when the rear portelement 630 is inserted into the first interior passageway 610.Alternatively, the outer surface 638 of the rear port element 630 caninclude one or more bumps which encircle the outer surface 638, wherethe one or more bumps have a diameter that is generally larger than theremainder of the outer surface 638 of the rear port element 630. Onceengaged, the outer surface 638 and the first interior passageway 610create a fluid tight seal. In one embodiment, a clamp element ispositioned around the tubular elongate body 606 to further secure therear port element 630 to the tubular elongate body 606. In oneembodiment, the clamp element is a suture which is tied around the outersurface of the tubular elongate body.

Alternatively, the outer surface 638 of the rear port element 630 canhave a tapered conical shape which increases in diameter from a firstpoint at or near the distal end of the lumen outlet 644 to a secondpoint proximal to the first point along the outer surface 638. In oneembodiment, the diameter of the outer surface 638 at the first point isless than the diameter of the first interior passageway 610 and thediameter of the outer surface 638 at the second point is greater thanthe diameter of the first interior passageway. The first point of theouter surface 638 is then inserted into the first interior passageway610 at the first opening 612 and moved longitudinally into the firstinterior passageway 610 until the outer surface 638 of the rear portelement 630 seats against inner surface of the first interior passageway610. In one embodiment, the rear port element is advanced into the firstinterior passageway 610 to create a fluid tight seal between the outersurface 638 of the rear port element 630 and the first interiorpassageway 610.

Alternatively, the outer surface 638 of the rear port element 630 canhave a diameter that is equal to or greater than the inner diameter ofthe first interior passageway 610. When the rear port element 630 isinserted into the first interior passageway 610, the outer surface 638of the rear port element 630 engages and seats against the inner surfaceof the first interior passageway 610. In one embodiment, a suture istied around the tubular elongate body 606 to further secure the rearport element 630 to the tubular elongate body 606. Alternatively, theinner surface of the rear port element 630 can have a diameter that isequal to or greater than the outer diameter of the tubular elongate body606. The inner surface of the rear port element 630 is then positionedaround the outer surface of the tubular elongate body 606 to form afluid tight seal.

In one embodiment, the tubular elongate body is constructed of at leastone polymer, where the polymer can include thermoplastics and/orthermoset polymers. Examples of polymers suitable for constructing thetubular elongate body include silicone, silicone elastomers,polyurethane, polyethylene, PEEK and/or PET. In one embodiment, thetubular elongate body is created from an extruded length of polymerhaving any number of cross-section shown in the present Figures.Alternatively, the tubular elongate body is formed by casting a polymerin a mold which defines the surfaces, or boundaries, of the tubularelongate body.

Additionally, the tubular elongate body has a length between theproximal end and the distal end in a range of between two (2)centimeters to fifty (50) centimeters, where, in one embodiment, thelength is determined by the size of the person and the position withinthe body that the implantable device is situated. In one embodiment, thelength of the tubular elongate body can be adjusted to an appropriatelength once the implantable device has been positioned within the body.The rear port element is then coupled to the elongate body andpositioned subcutaneously.

One reason for having a releasably attachable rear port is to reduce theoverall size (e.g., diameter) of the sheath used to introduce theimplantable device. Typically, the rear port element has a size (e.g.,one or more dimensions, such as an outer diameter) that is larger thanthe inner diameter of the sheath. Besides other potential problems, onedifficulty is either extending the sheath around the rear port element,or providing a rear port element that can be compressed to a size whichallows the implantable device to be moved through the sheath. In oneembodiment, this problem is solved by utilizing the implantable deviceshown in any one of FIG. 1, FIG. 2, FIG. 3, FIG. 4 and FIG. 6, where theimplantable device, absent the rear port element, is first slid throughthe sheath (FIGS. 1, 2, 3 and 6), or delivered through the use of thesleeve 424 (FIG. 4), the sheath removed from around the implantabledevice and the rear port element coupled to the tubular elongate body aswill be more fully described below.

In an alternative embodiment, an implantable device is provided wherethe device includes a rear port element, a tubular elongate body and anadjustable element. The distal end of the implantable device is thenpositioned within the channel of the sheath and is moved longitudinallywithin the sheath either through the use of a push rod introduced into asecond interior lumen, through force applied to the distal end of thetubular elongate body or through a sleeve moving within the sheath. Inone embodiment, once the implantable device has moved through the sheathto the point where the adjustable element is positioned within the body,the adjustable element is inflated, the sleeve (if present) is removed,and the sheath is then withdrawn from the body. In the embodiments wherea rear port element is present, however, the sheath must be passedaround the rear port element in order to remove the sheath from thebody.

Referring now to FIG. 7A, there is shown one embodiment of animplantable device assembly 700. The implantable device assembly 700includes an implantable device 704 and a sheath 708. The implantabledevice 704 is shown with a rear port element 712 positioned adjacent achannel opening 716 of the sheath 708. The sheath 708 fuirther includesa wall 720, where the wall 720 has at least a first portion 724 and asecond portion 728. In FIG. 7A, the second portion is shown as a firstarea of the wall that extends longitudinally along the body of thesheath 708, and a second area composes the remainder of the wall. In oneembodiment, the second portion 728 of the wall is of a lesser strengthas compared to the first portion 724 of the wall. This allows the sheath708 to be separated along the second portion 728. In one embodiment, thesheath 708 is separated along the second portion 728 by force applied tothe sheath 708 on either side of the second portion 728.

Referring now to FIG. 7B there is shown an embodiment of the implantabledevice assembly 700 where the sheath 708 is being separated along thesecond portion 728. As FIG. 7B shows, as the sheath 708 is separatedalong the second portion 728 the sheath 708 is opened into a more planarconfiguration. This planar configuration allows the sheath 708 to bepassed around the rear port element 712. Thus, the dimension of the rearport element no longer effects whether the implantable device 704 can beremoved from the sheath 708.

The sheath 708 shown in FIG. 7A and FIG. 7B is shown having one secondportion 728. A sheath having additional second portions is alsopossible. For example, the sheath 708 in FIG. 7C is shown having twosecond portions 728, where the each of the two second portions 728 arepositioned on opposite sides of the sheath 708.

Referring now to FIG. 8A there is shown one embodiment of a sheath 800according to the present subject matter. The sheath 800 includes a wall806 having an inner surface 812 and an outer surface 816. In oneembodiment, the inner surface 812 defines a channel 820 which passesthrough the sheath 800 from a first sheath opening 824 to a secondsheath opening 828 (shown with hidden lines). The channel 820 of thesheath 800 has a size which is appropriate to receive at least a portionof an implantable device, and through which at least a portion of theimplantable device can pass.

Sheath 800 also includes scorings, or a line of weakness, which extendlongitudinally along the wall 806 from a proximal end 834 to a distalend 836. In one embodiment, a first scoring 832 is provided whichextends longitudinally along the wall 806. In one embodiment, the firstscoring 832 provides the second portion of the wall that is of thelesser strength as compared to the first portion. In the presentembodiment, the second portion of the wall 806 is of lesser strength dueto the absence of, or the thinning, of the material comprising the wall806. In an alternative embodiment, the line of weakness is created by aplurality of closely spaced perforations, where the perforations extendthrough the wall 806. In one embodiment, the closely spaced perforationsextend longitudinally along the sheath to create the line of weakness.

In one embodiment, scoring of the wall 806 can be accomplished duringthe process of creating the sheath. For example, the sheath can becreated by extruding a polymer (or one or more polymers, includingco-polymers) through a die which includes one or more protrusions forcreating the scoring. Alternatively, the scoring could be accomplishedafter the sheath has been either extruded or cast, where the scoringsare added by either removing or deforming the sheath material to createthe region of lesser strength as compared to the remainder of the wall.Because of the lesser strength along the first portion, the sheath 800can be split along the first scoring 832 when sufficient force isapplied to the region of the first scoring 832 to cause the wall toseparate. In addition, a stress concentration point in the form of anotch or nick at a proximal edge of the scoring can be used to ensurethe sheath splits along the line, or path, of weakness.

Referring now to FIG. 8B, there is shown an additional embodiment of thesheath 800 according to the present subject matter. The embodiment ofthe sheath 800 in FIG. 8B is shown where the wall 806 includes twoscorings extending longitudinally along the wall 806 from a proximal end834 to a distal end 836 to allow for the sheath 800 to be separated intotwo pieces. In FIG. 8B, the two scorings include the first scoring 832and a second scoring 840. In one embodiment, the first and secondscorings 832 and 840 are positioned on opposite sides of the sheath 800.Alternatively, the first and second scorings 832 and 840 can be locatedat any position on the wall 806.

Referring now to FIG. 9, there is shown an alternative embodiment of asheath 900 according to the present subject matter. The sheath 900includes a wall 906 having an inner surface 912 and an outer surface916. In one embodiment, the inner surface 912 defines a channel 920which passes through the sheath 900 from a first sheath opening 924 to asecond sheath opening 928 (shown with hidden lines). The channel 920 ofthe sheath 900 has a size which is appropriate to receive at least aportion of an implantable device, and through which at least a portionof the implantable device can pass.

Sheath 900 also includes a first edge 930 and a second edge 932, wherethe first edge 930 and the second edge 932 are closely adjacent anddefine a slit 934 between the edges. The slit 934 passes through thewall 906 and extends longitudinally along the wall 906 from a proximalend 936 to a distal end 938. In one embodiment, the slit 934 providesthe second portion of the wall 906 that is of the lesser strength ascompared to the first portion. In the present embodiment, the secondportion of the wall 906 is of lesser strength due to the cut madethrough the wall 906. In one embodiment, creating the slit in the wall906 can be accomplished during the process of creating the sheath. Forexample, the sheath can be created by extruding a polymer (or one ormore polymers, including co-polymers) through a mold which has aprotrusion for creating the slit. Alternatively, the slit could beaccomplished after the sheath has been either extruded or cast, wherethe slit is added by cutting through the wall 906 along a path theextends longitudinally along the sheath 900. The presence of the slit934 allows the sheath to be separated at the slit 934 so that the sheathcan be passed around the implantable device (not shown). In oneembodiment, the sheath is constructed of a elastic material which isadapted to flex so as to allow the implantable device to pass throughthe slit in the sheath.

Referring now to FIG. 10, there is shown an additional embodiment of asheath 1000 according to the present subject matter. The sheath 1000includes a wall 1006 having an inner surface 1012 and an outer surface1016. In one embodiment, the inner surface 1012 defines a channel 1020which passes through the sheath 1000 from a first sheath opening 1024 toa second sheath opening 1028 opposite the first sheath opening 1024. Thechannel 1020 of the sheath 1000 has a size and a volume which isappropriate to receive at least a portion of an implantable device, andthrough which at least a portion of the implantable device can pass.

Sheath 1000 also includes a first edge 1030 and a second edge 1034 thatare spaced to define a slot 1038 in the wall 1006. In one embodiment,the distance between the first edge 1030 and the second edge 1034 isequal to or greater than the outer diameter of the tubular elongatebody. Alternatively, the distance between the first edge 1030 and thesecond edge 1034 is less than the outer diameter of the tubular elongatebody, where the tubular elongate body is constructed of an elasticpolymer which deforms to allow the tubular elongate body to pass throughthe slot 1038.

Alternatively, the slot is sufficiently large to afford the passage ofat least one of the rear port, tubular elongate body and/or theadjustable element of an implantable device through the slot 1038, whereany of the portions of the implantable device are deformable to allowthem to pass through the slot. In one embodiment, the wall 1006 hassufficient stiffness to maintain its shape when inserted into a body (aswill be described below) and when an implantable device is passed intothe channel, but yet has sufficient elasticity to allow the wall 1006 todeform as the implantable device is passed through the slot 1038.

Referring now to FIG. 11, there is shown an additional embodiment of thesheath 1000 according to the present subject matter. The sheath 1000further includes a layer 1100 over the outer surface 1016. In oneembodiment, the layer 1100 traverses, or extends over, the slot 1038 toform a continuous channel 1020 through the sheath 1000. In oneembodiment, the layer 1100 is made of a material which has a lesserstrength than the wall 1006 of the sheath 1000. In one embodiment, thelayer 1100 is adapted to develop a tear and to rip at leastlongitudinally along the major axis of the sheath as the implanteddevice is passed through the slot 1038 during insertion. Alternatively,the layer 1100 includes a slit 1110 which passes through the layer 1100,where the slit 1110 is adapted to allow the implanted device to passthrough the slot and the slit during insertion.

In one embodiment, the layer is formed by dipping, or casting the sheath1000 in a polymer in a softened state (either through heat for athermoplastic or pre-cross linked state for a thermosetting polymer),where the sheath 1000 is provided with a removable casting core whichfills the volume of the channel 1020 and allows the layer to be formedover the slot 1038. In one embodiment, the layer 1100 is formed frompolyurethane, Teflon, nylon, nylon elastomers, Pebax™, Polyethylene,silicone, or other flexible polymers or polymer blends as are known.

FIG. 12A shows one embodiment of an implantable device assembly 1200according to the present subject matter. The implantable device assembly1200 includes an implantable device 1204, having a rear port element1208, a tubular elongate body 1212 and an adjustable element 1216. Theimplantable device assembly 1200 also includes a sheath 1220, where inthe present embodiment the sheath 1220 includes a slot 1222 aspreviously described.

In one embodiment, as the sheath 1220 is removed from around theimplantable device 1204, the wall 1226 of the sheath is bent ordeformed, shown generally at 1230, to allow the components of theimplantable device 1204 to pass through the slot 1222. As the sheath1220 is being bent to allow the implantable device 1204 to pass throughthe slot 1222 the sheath can also be pulled in the general direction ofthe rear port 1208, which will be more fully understood later in thisdocument to be important in removing the sheath 1220 from a location ina body where an implantable device is desired.

FIG. 12B shows an additional embodiment of an implantable deviceassembly 1234 according to the present subject matter. The implantabledevice assembly 1234 includes an implantable device 1204, having a rearport element 1208, a tubular elongate body 1212 and an adjustableelement 1216. The implantable device assembly 1234 also includes asleeve 1236, where in the present embodiment the sleeve 1236 includes aslot 1238 and an inner surface 1240. In one embodiment, the innersurface 1240 defines a receptacle region 1244 which has a shape and asize to receive at least a portion of the rear port element 1208.

In the present embodiment, the implantable device 1204 is shown with theadjustable element 1216 in an expanded state. In one embodiment, theimplantable device 1204 is moved at least partially through a sheath(not shown) through force applied at the proximal end 1246 of the sleeve1236. As previously described, the distal end 1248 of the sleeve 1236abuts the ridge, or ledge, formed at the point where the tubularelongate body 1212 is connected to and sealed to the adjustable element1216. Once the implantable device 1204 has been positioned in the body,fluid is injected into the rear port element 1208 to inflate theadjustable element 1216. Once the adjustable element 1216 is inflated,the sheath is removed (as previously described). The sleeve 1236 is thenremoved from around the implantable device 1204 by first removing therear port element 1208 from the receptacle region 1244 and then passingthe tubular elongate body 1212 through the slot 1238 of the sleeve 1236.In the present embodiment, the sleeve 1236 is sufficiently stiff so thatthe walls of the sleeve 1236 flex very little, if at all, as the tubularelongate body 1212 deforms to pass through the slot 1238.

Referring now to FIG. 13, there is shown a schematic view of theimplantable device assembly 1300 according to one embodiment of thepresent subject matter. The implantable device assembly 1300 is shown toinclude an implantable device 1302 which has an adjustable element 1304and a tubular elongate body 1306. In one embodiment, the adjustableelement 1304 includes a continuous wall 1308, including an inner surface1310 defining a chamber 1316. The tubular elongate body 1306 includes aperipheral surface 1320, a proximal end 1326 and a distal end 1328. Inone embodiment, the peripheral surface 1320 is connected to and sealedto the adjustable element 1304 as previously described.

The tubular elongate body 1320 also includes at least a first interiorpassageway 1330 which extends longitudinally in the tubular elongatebody 1320 from a first opening 1332 at the proximal end 1326 to a secondopening 1334. In one embodiment, the second opening 1334 is in fluidcommunication with the chamber 1316 of the implantable device 1302 foradjustably expanding or contracting the adjustable element 1304 byflowable material introduced through the first opening 1332.Additionally, a detectable marker 1333 is located at or on the distalend of the tubular elongate body 1320 to allow for the position of theimplantable device 1300 be located within the tissues of a patient.Alternatively, the detectable marker is imbedded in the continuous wallof the adjustable element 1304.

In one embodiment, the first interior passageway 1330 includes a closedend 1340, where the closed end 1340 is positioned distal to both thefirst opening 1332 and second opening 1334. The closed end 1340 is ofsufficient strength and hardness to receive a distal end 1342 of a pushrod 1344, where the closed end 1340 transfers force applied at aproximal end 1346 of the push rod 1344 to the implantable device 1300.In one embodiment, the first interior passageway 1330 is of sufficientdiameter to receive the push rod 1344 which contacts the closed end 1340to allow force applied to the push rod 1344 to move the implanted device1302.

The implantable device assembly 1300 further includes a tip 1350. In oneembodiment, the distal end 1328 of the tubular body 1320 forms the tip1350. In one embodiment, the tip 1350 is suitable to penetrate thetissue of a patient, where the tip 1350 includes at least a distal end1354 which is sharped to afford the ability to insert the tip 1350 andthe implantable device 1302 into the tissue of a patient. Thisconfiguration of the implantable device assembly 1300 allow for theimplantable device 1302 to be delivered into the tissue of the patientwithout the need for a sheath. The tip also has a conical configurationto allow for the tissue being penetrated by the implantable device 1302to pass over the tip 1350 and the body of the implantable device 1302.In an additional embodiment, the tip 1350 further includes one or moresharpened edges which extend from the distal end 1354 of the tip 1350toward a proximal end 1358 of the tip 1350. In an additional embodiment,the adjustable element 1304 is adapted to expand under pressure from avolume of flowable material introduced through the first opening to atleast partially envelop the tip 1350.

The present embodiment shows an example of a “self-dilating” device,where the implantable device is used to create its own pathway into thebody of the patient. An advantage of the present embodiment is that thesize of the opening created for inserting the implantable device is keepto a minimum, as only a channel the approximate size of the implantabledevice is created. Also, the surgical procedure is expedited as thereare fewer items (e.g., obturator, sheath etc.) to insert prior to theactual delivery of the implantable device.

The tip 1350 used on the implantable device 1302 can be constructed of avariety of materials. In one embodiment, the tip 1350 is made of a hardplastic, such as polyurethane or PET. Alternatively, the tip 1350 isconstructed of a biodegradable, or bioabsorbable, material, such aspolyglycolic acid or polylactic acid, a dissolvable material such as astarch, or a material that is initially hard, but becomes soft afterexposure to moisture, such as a hydrogel material. In this embodimentthe tip is bonded to the distal end 1328 of the tubular elongate body.In one embodiment, the bonding is accomplished with a medical gradeadhesive, such as silicone. Alternatively, the tip 1350 is cast onto thedistal end 1328 of the tubular elongate body 1320, where the distal end1328 has been configured and shaped to receive the tip material so as tolock the tip 1350 in place.

The implantable device assembly 1300 further includes a rear portelement 1360, which is releasably coupled to the proximal end 1326 ofthe tubular elongate body 1320. The rear port element 1360 is similar tothe rear port element previously described, and is adapted to be coupledto the tubular elongate body 1320 to create a fluid tight seal betweenthe outer surface of the rear port element 1360 and the inner surface ofthe first interior passageway of the tubular elongate body 1320.

Referring now to FIG. 14, there is shown an additional embodiment of animplantable device assembly 1400 according to the present subjectmatter. The implantable device assembly 1400 is shown to include animplantable device 1402 which has an adjustable element 1404 and atubular elongate body 1406. The tubular elongate body 1406 includes aperipheral surface 1420, a proximal end 1426 and a distal end 1428. Inone embodiment, the peripheral surface 1420 is connected to and sealedto the adjustable element 1404 as previously described. In oneembodiment, the adjustable element 1404 includes a continuous wall 1408,including an inner surface 1410 defining a chamber 1416 and at least onedetectable marker 1411 positioned at the distal end 1428 of the tubularelongate body 1406. Alternatively, the maker 1411 can be embedded in thecontinuous wall of the adjustable element 1404 to allow for the positionof the implantable device 1400 to be located and its shape to bevisualized within the tissues of a patient. Detectable markers can alsobe embedded in the tubular elongate body 1406.

The tubular elongate body 1406 includes a first interior passageway 1430and a second interior passageway 1432. In one embodiment, the firstinterior passageway 1430 extends longitudinally in the tubular elongatebody 1406 from a first opening 1434 at the proximal end 1426 to a secondopening 1436. The second opening 1436 is in fluid communication with thechamber 1416 of the implantable device for adjustably expanding orcontracting the adjustable element 1404 by flowable material introducedthrough the first opening 1434, as previously described.

The second interior passageway 1432 extends longitudinally along atleast a portion of the tubular elongate body 1406 from an inlet 1444 toan outlet 1446. In one embodiment, the second interior passageway 1432is of sufficient diameter to receive a push rod 1450. The push rod 1450has a proximal end 1454 and a distal end 1458, where the distal end 1458of the push rod 1450 has a tip 1460 which is has a sharp point. In oneembodiment, the sharp tip 1460 of the push rod 1450 extends through theoutlet 1446 of the second interior passageway 1432 to provide theinitial cutting tip of the implantable device apparatus 1400. In oneembodiment, the distal end 1428 of the tubular elongate body 1420 has aconical taper which extends from the tip 1460 to allow the distal end1428 to create a uniform conical shape suitable for penetrating tissue.

In one embodiment, to position the push rod 1450 within the secondinterior passageway 1432 with only the tip 1460 protruding from thedistal end 1428, there is provided a first shoulder 1470 in the secondinterior passageway 1432 against which a corresponding second shoulder1474 on the push rod 1450 seats. In one embodiment, the first shoulder1470 is formed by a change in diameter of the second interior passageway1432, where the inner surface 1478 of the second interior passageway1432 changes from having a first passageway diameter to a secondpassageway diameter, where the second diameter is smaller than the firstdiameter. The second shoulder 1474 is also formed by a change indiameter of the push rod 1450, where the exterior surface of the pushrod 1450 changes from having a first rod diameter to a second roddiameter. Once the push rod 1450 is inserted into the second channel itis advanced so that the second shoulder 1474 abuts the first shoulder1470 and so that the tip 1460 protrudes from the distal end 1428. Forceapplied to the push rod 1450 can then be transferred to the implanteddevice 1402 so that it may be advanced into the tissue of a patient.

The implantable device assembly 1400 further includes a rear portelement 1480, which is coupled to the proximal end 1426 of the tubularelongate body 1420. In one embodiment, the rear port element 1480 issimilar to the rear port element previously described, and is adapted tobe releasably coupled to the tubular elongate body 1420 to create afluid tight seal between the outer surface of the rear port element 1480and the inner surface of the first interior passageway of the tubularelongate body 1420.

Referring now to FIG. 15 there is shown a schematic cross-sectional viewof an implantable device assembly 1500 according to one embodiment ofthe present subject matter. As previously described, the implantabledevice assembly 1500 includes an implantable device 1502 having anadjustable element 1504 and a tubular elongate body 1506, where thetubular elongate body 1506 includes at least a first interior passageway1510 which extends longitudinally in the tubular elongate body 1506 froma first opening 1512 at the proximal end 1516 to a second opening 1520.The implantable device assembly 1500 also includes a tip 1524, where thetip 1524 has a end suitable for insertion of a tip and device intotissue of the patient as previously discussed.

The implantable device assembly 1500 further includes a rear portelement 1530, where the rear port element 1530 is coupled to theproximal end 1516 of the tubular elongate body 1506. The rear portelement 1530 includes a cavity 1532 in fluid communication with thefirst opening 1512 of the first interior passageway 1510. In oneembodiment, the rear port element 1530 also includes an elastic septum1540 through which the cavity 1532 is accessed. In one embodiment, theelastic septum 1540 has a structure, a size and function as previouslydescribed. As shown in FIG. 15, the elastic septum 1540 has a bulbousconfiguration.

In the present embodiment, the tubular elongate body 1506 has astiffness sufficient to allow force applied at the proximal end of thetubular elongate body 1506 to move the implantable device 1502 throughsoft tissue of a patient. In one embodiment, the stiffniess of thetubular elongate body is determined based on the type of material usedin constructing the tubular elongate body. Alternatively, supportelements can be added to the tubular elongate body. For example, a metalcoil 1550 is placed longitudinally within the tubular elongate body toincrease the stiffness of the tubular elongate body 1506. In oneembodiment, the metal coil 1550 allows force applied along thelongitudinal axis of the implantable device 1502 to be transferred tothe tip 1524.

FIG. 15 also shows one embodiment of the adjustable element 1504 in aninflated state. In the present embodiment, the adjustable element 1504is adapted to partially envelop the tip 1524. One reason for envelopingthe tip with the adjustable element 1504 is to protect the tissue in theimplant area from the tip 1524. The example in FIG. 15 is just oneexample of a tip being enveloped by the adjustable element, and otherconfigurations of enveloping the tip can be imagined, such as the tipbeing completely surrounded by the adjustable element.

Referring now to FIG. 16, there is shown one embodiment of a method foradjustably restricting a body lumen according to the present subjectmatter. The implantable device assembly previously discussed is adaptedto be surgically implanted into body tissue of a patient adjacent to abody lumen for coaptating the body lumen. At 1600, a sheath isintroduced into body tissue of a patient. In one embodiment, the sheathis as previously described, where the sheath is introduced by firstplacing an obturator having an end suitable for penetrating tissuethrough the channel of the sheath. Once the body lumen, such as theurethra, is located a small incision is made in the skin and theobturator is used to introduce the sheath into the body tissue to adesired location adjacent the urethra. This procedure is usually carriedout under a local anesthetic with visual guidance, for instance underfluoroscopy by a physician. The obturator is of sufficient strength andrigidity to allow the insertion of the sheath into the tissue of thepatient adjacent and parallel with the urethra.

In one embodiment, the sheath is inserted near the meatus urinarius andadvanced through the periurethral tissue adjacent the urethra. In oneembodiment, a detent or mark is provided on the sheath to ensure thatthe sheath is appropriately placed at the correct depth in the patient'sbody tissue. In an additional embodiment, the elongate body of theimplantable medical device is available having a variety of lengths toaccommodate the patient's anatomic structure so as to facilitateplacement of the rear port element near the patient's skin. In oneembodiment, the tubular elongate body of the implantable device onceinserted into the patient's tissue can be cut to length prior toattaching the rear port element.

As previously described, the sheath includes a channel having alongitudinal axis and one or more dimensions perpendicular to thelongitudinal axis. An example of the one or more dimensions includes adiameter of the channel, where the channel has a circular cross-section.Alternatively, the channel may have an elliptical cross-section, wherethe dimensions then have a major and a minor axis which define theellipse.

At 1610, an implantable device is inserted at least partially throughthe channel of the sheath. In one embodiment, the implantable deviceincludes an adjustable element, a tubular elongate body and a rear portelement, as were previously described. In the present embodiment, therear port element further includes at least one dimension that is largerthan the one or more dimensions of the sheath. Examples of these werenoted in the figures and the discussion for FIGS. 5 to 12 of the presentsubject matter. By way of example, at least one dimension that is largerthan the one or more dimensions of the sheath can include the diameterof the outer surface of the rear port element and the inner diameter ofthe sheath. In this situation, the implantable device would not passthrough the channel of the sheath as the diameter of the rear portelement is larger than the diameter of the sheath.

The implantable medical device is advanced or moved at least partiallythough the channel to position the adjustable element distal to thesheath and adjacent the body-lumen to be restricted. In one embodiment,the adjustable element is positioned adjacent an urethra. In anadditional embodiment, two or more of the implantable medical devicescan be implanted within the body tissue adjacent an urethra. Theadjustable element is then expanded, or inflated, so as to retain theimplantable medical device prior to removing the sheath.

At 1620, the sheath is then passed around the rear port element as thesheath is removed from the body tissue. In one embodiment, this isaccomplished by splitting the sheath into one or more pieces aspreviously described. One manner of providing a sheath that will spiltis to create one or more scores on the sheath as previously described.The scores in the wall of the sheath provide lines of weakness, wherethe sheath can be torn along these one or more scores to allow thesheath to be passed around the rear port element as the sheath isremoved from the body tissue.

In an additional embodiment, the sheath can have a slit as previouslydescribed, where the sheath is made of a material having the flexibilityto allow the sheath to pass around the rear port element by passing theelongate body of the implantable device through the slit as the sheathis removed from the body tissue. Alternatively, the sheath can have aslot as previously described, where the sheath is made of a materialhaving a stiffness that requires the tubular elongate body of theimplantable device to deform as it passes through the slot as the sheathis removed from the body tissue. The rear port element is then positionsubcutaneously.

After the implantable medical device has been implanted so theadjustable element (in its contracted state) is in the desired positionadjacent to the urethra, the urethra is restricted to a desired degreeby piercing the elastic septum of the rear port with a needle of asyringe and injecting a flowable material through the first interiorpassageway into the adjustable element. The physician may determine thedesired degree of restriction of the urethra by means such as infusingfluid through the urethra past the restriction and measuring the backpressure or visually assessing the amount of coaptation of the urethralumen after inflation of the adjustable element by use of cystoscopy.The flowable material may be, for example, a saline solution, a flowablegel, or a slurry of particles in a liquid carrier. It may beadvantageous to make the flowable material radiopaque so that the degreeof membrane inflation may be viewed by x-ray.

One feature of this invention relates to the adjustability of theadjustable element postoperatively. This adjustability is effectedbecause the elastic septum is located remote from the adjustable elementbut near and under the patient's skin. The rear port element and theelastic septum are located by, for instance, manual palpation of theskin region and the needle of the syringe is inserted through the skinand septum so as to add or remove material from the adjustable element,thus increasing or decreasing the restriction of the body lumen.

In an additional embodiment, the rear port element can have any numberof shapes that is more easily identifiable in the tissue duringpalpation by a physician. For example, the rear port element can have aoval cross-sectional shape. Alternatively, the rear port element canhave a square cross-sectional shape. Other cross-sectional shapes can beimagined which would assist a physician in locating the rear portelement. Additionally, the elastic septum of the rear port element canbe positioned at a level that is higher (e.g., domed or bulbous), orlower, than that rear port element wall surrounding the elastic septum.This configuration assists the physician in finding the elastic septumquickly as it is set apart from the remainder of the rear port element.The rear port element can then be utilized for preforming post-operativeadjustments (e.g., days, weeks, months, years) of the size of theadjustable element.

1. An implantable device assembly, comprising: an implantable deviceadapted to be implanted within body tissue adjacent to a body lumen forcontrollable coaptation of the body lumen, the implantable deviceincluding an adjustable element and a tubular elongate body, wherein theadjustable element includes a continuous wall, including an innersurface defining a chamber, and the tubular elongate body includes aperipheral surface, a proximal end and a distal end, where theperipheral surface is connected to and sealed to the adjustable element,the tubular elongate body including at least a first interior passagewaywhich extends longitudinally in the tubular elongate body from a firstopening at the proximal end to a second opening in fluid communicationwith the chamber of the implantable device for adjustably expanding orcontracting the adjustable element by applied flowable materialintroduced though the first opening; and a sheath configured toaccommodate at least a portion of the implantable device, the sheathbeing radio opaque.
 2. An implantable device assembly, comprising: apush rod including a first end and a second end, the first end having asharp tip; and an implantable device adapted to control coaptation of abody lumen, the implantable device including: an adjustable elementincluding a continuous wall having an inner surface defining a chamber;and a tubular elongate body including a peripheral surface, a proximalend, a distal end, a first interior passageway, and a second interiorpassageway, the peripheral surface connected to and sealed to theadjustable element near the distal end, the first interior passagewayhaving a first opening at the proximal end and a second opening in fluidcommunication with the chamber, the second interior passageway having aninlet configured to receive a portion of the push rod and an outletconfigured to allow the sharp tip of the push rod to extend beyond theoutlet and the distal end.
 3. The implantable device assembly of claim2, wherein the distal end of the tubular elongate body comprises aconical taper configured to provide a uniform conical shape with thesharp tip of the push rod, the uniform conical shape suitable forpenetrating body tissue.
 4. The implantable device assembly of claim 2,wherein the implantable device comprises a first shoulder in the secondinterior passageway, and the push rod comprises a second shoulderconfigured to abut the first shoulder such that the sharp tip of thepush rod protrudes from the distal end of the tubular elongate body. 5.The implantable device assembly of claim 4, wherein the first shoulderis formed by a change in diameter of the second interior passageway. 6.The implantable device assembly of claim 5, wherein the second shoulderis formed by a change in diameter of the push rod.
 7. The implantabledevice assembly of claim 2, wherein the implantable device comprises arear port element coupled to the proximal end of the tubular elongatebody, the rear port element including a cavity in fluid communicationwith the first opening of the first interior passageway.
 8. Theimplantable device assembly of claim 7, comprising a flowable materialsource adapted to be releasably connected to the rear port element, andwherein the adjustable element expands or contracts due to a volume of aflowable material introduced into the cavity of the rear port elementfrom the flowable material source.
 9. The implantable device assembly ofclaim 7, wherein the rear port element is releasably coupled to theproximal end of the tubular elongate body.
 10. The implantable deviceassembly of claim 7, wherein the rear port element comprises an elasticseptum configured to receive a needle through which a flowable materialis introduced to expand or contract the adjustable element.
 11. Theimplantable device assembly of claim 2, wherein the implantable devicecomprises a detectable marker positioned at the distal end of thetubular elongate body.
 12. An implantable device assembly, comprising: apush rod; an implantable device adapted to control coaptation of a bodylumen, the implantable device including: an adjustable element includinga continuous wall having an inner surface defining a chamber; and atubular elongate body including a peripheral surface, a proximal end, adistal end, and a first interior passageway, the peripheral surfaceconnected to and sealed to the adjustable element near the distal end,the first interior passageway configured to accommodate at least aportion of the push rod and having a first opening at the proximal end,a second opening in fluid communication with the chamber, and a closedend configured to receive the push rod to allow force applied to thepush rod to move the implantable device; and a sheath adapted toaccommodate at least a portion of the implantable device.
 13. Theimplantable device assembly of claim 12, wherein the sheath comprises adetectable marker.
 14. The implantable device assembly of claim 12,wherein the sheath is radio opaque.
 15. The implantable device assemblyof claim 12, wherein the adjustable element comprises a biocompatibleresiliently elastomeric polymer or polymer blend.
 16. The implantabledevice assembly of claim 12, wherein the adjustable element comprises abiocompatible non-resilient polymer or polymer blend.
 17. Theimplantable device assembly of claim 12, wherein the continuous wall ofthe adjustable element is configured to expand to a predetermined shape.18. The implantable device assembly of claim 17, wherein the continuouswall comprises an outer surface generally defining a spherical shape.19. The implantable device assembly of claim 17, wherein the continuouswall comprises an outer surface generally defining an elongate bodyhaving semi-spherical end portions.
 20. The implantable devicve assemblyof claim 17, wherein the implantable device comprises a detectablemarker configured to allow the adjustable element to be located withinbody tissue.
 21. The implantable device assembly of claim 20, whereinthe detectable marker comprises tantalum.